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Study of Promethazine for Treatment of Diabetic Gastroparesis

Primary Purpose

Diabetic Gastroparesis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Promethazine
Sugar pill
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Gastroparesis focused on measuring Diabetic Gastroparesis, Promethazine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adult patients 18-65 years of age
  • clinical diagnosis of diabetic gastroparesis.
  • EGD without evidence of gastric outlet obstruction within the past five years
  • gastric emptying scintigraphy test demonstrating >10% solid food retention at 4 hours within the past three years.

Exclusion Criteria:

  • the inability or unwillingness to provide informed consent
  • currently pregnant or breast feeding
  • prior placement of a gastric stimulator
  • pyloric botulinum toxin injection within the past 12 months
  • prior gastric surgery
  • history of a connective tissue disorder
  • use of narcotic medication within the past four weeks
  • hemoglobin A1C >12 mg/dL within the past 3 months
  • current or recent (within past 4 weeks) use of promethazine, metoclopramide or domperidone
  • hypersensitivity or prior adverse reaction to promethazine
  • concomitant use of phenothiazines (i.e. prochlorperazine, chlorpromazine) or other agents likely to increase extrapyramidal reactions
  • concomitant use of tiotropium or ipratropium
  • narrow angle glaucoma
  • urinary retention
  • Parkinson's disease
  • significant psychiatric disease
  • history of seizure.

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Promethazine

Sugar Pill

Arm Description

Promethazine 12.5 mg P.O. t.i.d. for 4 weeks

Placebo P.O. t.i.d. for 4 weeks

Outcomes

Primary Outcome Measures

Change in Patient-reported Symptoms as Measured by the Gastroparesis Cardinal Symptom Index Score (GCSI, 14) From Week 0 to Week 4.

Secondary Outcome Measures

Occurrence of Adverse Events
Use of Rescue Medication
Frequency of use of the "rescue medication" meclizine
The Impact on Work Activity as Measured by the Work Productivity and Activity Impairment Questionnaire. (WPAI).

Full Information

First Posted
May 1, 2014
Last Updated
July 9, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
American College of Gastroenterology
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1. Study Identification

Unique Protocol Identification Number
NCT02130622
Brief Title
Study of Promethazine for Treatment of Diabetic Gastroparesis
Official Title
A Pilot, Randomized, Double-blind, Placebo-controlled Trial of Promethazine for Treatment of Diabetic Gastroparesis.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
July 2014 (Actual)
Primary Completion Date
May 14, 2015 (Actual)
Study Completion Date
May 14, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
American College of Gastroenterology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed gastric emptying will be recruited to participate in the study. Using double-blinded methodology, study participants will be randomly assigned to one of two treatment arms: promethazine 12.5 mg three times daily for 28 days or placebo three times daily for 28 days. The primary outcome will be the change in gastroparesis symptom severity, as measured by the Gastroparesis Cardinal Symptom Index (GCSI) at four weeks compared to baseline. Participants will be seen for a clinic evaluation at weeks 0, 2 and 4, during which symptom scores, adverse events and treatment compliance will be assessed. It is hypothesized promethazine treatment will be superior to placebo in improving symptoms of gastroparesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Gastroparesis
Keywords
Diabetic Gastroparesis, Promethazine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Promethazine
Arm Type
Experimental
Arm Description
Promethazine 12.5 mg P.O. t.i.d. for 4 weeks
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Placebo P.O. t.i.d. for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Promethazine
Other Intervention Name(s)
Phenergan
Intervention Type
Drug
Intervention Name(s)
Sugar pill
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Patient-reported Symptoms as Measured by the Gastroparesis Cardinal Symptom Index Score (GCSI, 14) From Week 0 to Week 4.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Occurrence of Adverse Events
Time Frame
4 weeks
Title
Use of Rescue Medication
Description
Frequency of use of the "rescue medication" meclizine
Time Frame
4 weeks
Title
The Impact on Work Activity as Measured by the Work Productivity and Activity Impairment Questionnaire. (WPAI).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adult patients 18-65 years of age clinical diagnosis of diabetic gastroparesis. EGD without evidence of gastric outlet obstruction within the past five years gastric emptying scintigraphy test demonstrating >10% solid food retention at 4 hours within the past three years. Exclusion Criteria: the inability or unwillingness to provide informed consent currently pregnant or breast feeding prior placement of a gastric stimulator pyloric botulinum toxin injection within the past 12 months prior gastric surgery history of a connective tissue disorder use of narcotic medication within the past four weeks hemoglobin A1C >12 mg/dL within the past 3 months current or recent (within past 4 weeks) use of promethazine, metoclopramide or domperidone hypersensitivity or prior adverse reaction to promethazine concomitant use of phenothiazines (i.e. prochlorperazine, chlorpromazine) or other agents likely to increase extrapyramidal reactions concomitant use of tiotropium or ipratropium narrow angle glaucoma urinary retention Parkinson's disease significant psychiatric disease history of seizure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian E. Lacy, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

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Study of Promethazine for Treatment of Diabetic Gastroparesis

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